Chronic Lymphocytic Leukemia Clinical Trial
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Summary
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory leukemia-cll/" >CLL and require treatment in opinion of investigator.
Eastern Cooperative Oncology Group (ECOG) <= 1.
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.
Exclusion Criteria:
History or is clinically suspicious for cancer-related Central Nervous System disease.
Receipt of allogenic or autologous stem cell transplant.
Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
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There are 10 Locations for this study
La Jolla California, 92093, United States
Boston Massachusetts, 02215, United States
Omaha Nebraska, 68198, United States
New Hyde Park New York, 11040, United States
Houston Texas, 77030, United States
Tacoma Washington, 98405, United States
Melbourne Victoria, 3000, Australia
Parkville Victoria, 3050, Australia
Köln Nordrhein-Westfalen, 50937, Germany
Leicester England, LE1 5, United Kingdom
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